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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Rheumatoid Factor
510(k) Number K800268
Device Name AUTOMATED RHEMATOID FACTOR TEST (ARFT)
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Regulation Number866.5775
Classification Product Code
DHR  
Date Received02/06/1980
Decision Date 02/21/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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